Breast CancerNCT05396612
Role of the Immune Environment in Response to Therapy in Breast Cancer
An observational study of Breast Cancer and ER Positive Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This is an observational case-control study of tissues collected from women with ER+HER2- breast cancers. The immune environments of these cancers will be compared to triple negative and HER2+ breast cancers. No randomization or changes to standard of care treatment will occur as part of the study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, ER Positive Breast Cancer, HER2-negative Breast Cancer
- What is being tested?
- Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women 18 years of age or older undergoing surgery for breast cancer.
Who may be able to join
- Women 18 years of age or older with non-metastatic breast cancer undergoing surgical resection in the University of Pennsylvania Health System.
Who cannot join
- Males Children Pregnant individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
About this study
This is an observational case-control study of tissues collected from women with ER+HER2- breast cancers. The immune environments of these cancers will be compared to triple negative and HER2+ breast cancers. No randomization or changes to standard of care treatment will occur as part of the study.
- Conditions
- Breast Cancer, ER Positive Breast Cancer, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
- Being tested
- Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.
- Keywords
- Immune microenvironment
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.Other
Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.
What is being measured
The primary outcome is the main question the study is designed to answer.
Collecting, processing and archiving breast cancer tumor tissues
This study will collect and analyze tumor samples from women diagnosed with primary breast cancer. The investigators will dissociate fresh tumor samples and analyze single cell suspensions by flow cytometry. Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between breast cancer subtypes (HR+HER2-, HER2+, triple negative). Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between HR+HER2- untreated breast cancers compared to HR+HER2- chemotherapy treated breast cancers.
Measured: Through study completion, average of 2 years
Secondary outcomes (1)
Associating breast cancer dendritic cell infiltrate with outcome
We will perform studies to associate dendritic cell infiltration and activation markers with patient outcome, including disease free survival, distant disease free survival, and overall survival.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start3 Oct 2022
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Zhang, Abramson Cancer Center at Penn Medicine
- Investigators
- Jennifer Zhang, MD, Principal investigator, Abramson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396612
- Sponsor's protocol ID
- UPCC 19121
- Other IDs
- 850338
- Status last verified
- Jul 2025
- First submitted
- 5 May 2022
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Immune Environment in Response to Therapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT05396612
- Acronym / sponsor ID
- UPCC 19121
- Conditions
- Breast Cancer, ER Positive Breast Cancer, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
- Keywords
- Immune microenvironment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational case-control study of tissues collected from women with ER+HER2- breast cancers. The immune environments of these cancers will be compared to triple negative and HER2+ breast cancers. No randomization or changes to standard of care treatment will occur as part of the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women 18 years of age or older undergoing surgery for breast cancer.
Key inclusion criteria (1 listed)
- Women 18 years of age or older with non-metastatic breast cancer undergoing surgical resection in the University of Pennsylvania Health System.
Key exclusion criteria (1 listed)
- Males Children Pregnant individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver. | Other | – |
Primary outcome
Collecting, processing and archiving breast cancer tumor tissues
Time frame: Through study completion, average of 2 years
This study will collect and analyze tumor samples from women diagnosed with primary breast cancer. The investigators will dissociate fresh tumor samples and analyze single cell suspensions by flow cytometry. Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between breast cancer subtypes (HR+HER2-, HER2+, triple negative). Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between HR+HER2- untreated breast cancers compared to HR+HER2- chemotherapy treated breast cancers.
1 secondary outcome
Associating breast cancer dendritic cell infiltrate with outcome
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Zhang, MD principal investigator
Abramson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and ER Positive Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia T. Lewandowski (215-662-2861, Julia.Lewandowski@Pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collecting, processing and archiving breast cancer tumor tissues (time frame: Through study completion, average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.